Ketoprofen is a well-known non-steroidal anti-inflammatory drug (NSAID). Ketoprofen is commercially-available in traditional tablet form, which is to be swallowed with liquids. The traditional tablet dosage form may not be appropriate for certain classes of individuals, such as young children or the geriatric population who have difficulty swallowing. Furthermore, the traditional tablet dosage form requires access to water or other potable liquids to aid in the administration of the tablet dosage form.
In an effort to overcome the difficulties associated with self-administration of the traditional tablet dosage form, orally disintegrating dosage forms, such as thin films or orally disintegrating tablets for delivering a pharmacologically active agent via the oral cavity have been developed. The thin films are generally thin strip solid dosage forms incorporating a pharmacologically active agent, and which disintegrate in the oral cavity to release the active agent that is incorporated in the film. A wide variety of pharmacologically active agents have been incorporated into disintegrable thin film dosage forms.
Ketoprofen is a propionic acid derivative and has an unpleasant bitter taste. Ketoprofen is also known to irritate the throat mucosa. Accordingly, disintegrable ketoprofen-containing oral thin film or disintegrable oral tablet dosage forms would be considered by those having ordinary skill in the art to be undesirable as being unpalatable.
U.S. Patent Application Publication No. 2002/0169212 discloses a stable solution of ketoprofen in water for mass medicating animals. The solution is prepared by mixing ketoprofen with an edible weak base and water. The edible weak base is used in combination with ketoprofen in a ratio of 10 to 1 to completely and rapidly solubilize the ketoprofen in cold water. It is disclosed that flavoring or sweetening agents are added to the ketoprofen solution to increase the palatability of the solution. This publication, however, does not disclose or suggest a solid dosage form containing a taste masked ketoprofen active.
Thus, there remains a need in the art for solid dosage forms, such as disintegrating oral films, that deliver an effective dose of the pharmacologically active agent ketoprofen to the oral cavity, and which are not accompanied by the usual bitter taste of ketoprofen or irritation to the oral and throat mucosa.